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A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)
A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

NCT05738486

Active Not RecruitingPhase 3

Sponsor: Eli Lilly and Company

Conditions: Alzheimer's Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases

Interventions: Donanemab, Placebo, Dexamethasone

Countries: United States, United Kingdom

This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA. Approximately 375 additional participants will be enrolled in addendum 2. Addendum 3 includes a subset of participants from the main study to receive a single dose. The study will last approximately 91 weeks and include up to 26 visits in the main study.

Eligibility overview

Sex: ALL

Age: 60 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Gradual and progressive change in memory function reported by the participant or informant for ≥6 months.
* A mini mental state examination (MMSE) score of 20 to 28 (inclusive) at screening.
* Have an amyloid PET scan result from central read, consistent with the presence of amyloid pathology.

Exclusion Criteria:

* Have significant neurological disease affecting the central nervous system other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures, except febrile childhood seizures.
* Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study.
* A life expectancy of \<24 months.
* Contraindication to MRI or PET scans
* Have had prior treatment with a passive anti-amyloid immunotherapy.
* Have a presence or history of malignant neoplasms within the past 5 years prior to Visit 1.

Exceptions:

* non-metastatic basal- or squamous-cell skin cancer
* Stage 0 non-invasive carcinoma of the cervix
* Stage 0 non-invasive prostate cancer, or
* other cancers with low risk of recurrence or spread
Locations (49)
  • Chandler, Arizona, United States
  • Irvine, California, United States
  • Long Beach, California, United States
  • Sherman Oaks, California, United States
  • Atlantis, Florida, United States
  • Aventura, Florida, United States
  • Boca Raton, Florida, United States
  • Clermont, Florida, United States
  • Delray Beach, Florida, United States
  • Fort Myers, Florida, United States
  • Greenacres City, Florida, United States
  • Hollywood, Florida, United States
  • Jacksonville, Florida, United States
  • Maitland, Florida, United States
  • Maitland, Florida, United States
  • Melbourne, Florida, United States
  • New Port Richey, Florida, United States
  • Ocala, Florida, United States
  • Orlando, Florida, United States
  • Port Orange, Florida, United States
  • Stuart, Florida, United States
  • Tampa, Florida, United States
  • The Villages, Florida, United States
  • The Villages, Florida, United States
  • Wellington, Florida, United States
  • West Palm Beach, Florida, United States
  • Winter Park, Florida, United States
  • Columbus, Georgia, United States
  • Decatur, Georgia, United States
  • Gainesville, Georgia, United States
  • + 19 more on CT.gov